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REACH Corner

Regulatory Affairs Column

SCC Cosmegram

May 2017

REACH Deadline for Pre-Registration of Products Sold in the EU Rapidly Approaching!

May 31, 2017

What is REACH?

REACH is an acronym for Registration, Evaluation, and Authorization of Chemicals in Europe. It is a mandatory E.U. Chemicals Registration Program that quantifies the safety and effects of chemicals on people and the environment.Any company that does business in Europe must be clear on their responsibilities.Any American company that imports products or chemicals must be represented in the E.U. under REACH (called an “Only Representative”).The Only Representative must be familiar with chemicals and be able to participate in highly technical discussions involving toxicology and chemistry with this complicated requirement.

How do I know if I have to register?

If you are selling products into any of the 28 EU Member States, those products must have all eligible ingredients fully registered. Full toxicological files ultimately need to be submitted for each chemical.

What is pre-registration?

Certain chemicals are eligible for pre-registration. Those that have previously been assigned EINECS numbers generally can be submitted under a pre-registration. Pre-registration does not remove the requirement for full registration, but it does extend the time by a year to do a full registration by the May 31, 2018 deadline.

Why is a pre-registration an advantage?

Pre-registration does not require a full toxicological profile of the ingredient, and simply notifies ECHA of your intent to register. There are no government fees for this process, though it does have to be completed by a European entity.

How much time do I have to pre-register?

Not much. The pre-registration period is expiring on May 31, 2017. Any ingredient that is imported in quantities equal to one ton or over (per product line) must be in ECHA’s system by that date. If the May 31 pre-registration deadline is not met, the ingredient is subject to immediate full registration, with a complete toxicological data file and fees due to the government.

If I am a Cosmetic product marketer, why should I care?

If a chemical enters Europe, even if it is only contained in a finished product, it falls under this Regulation. So if an American company exports Cosmetics to Europe, the chemicals in those products must be registered.

Who is responsible for Enforcement?

The European Chemicals Agency, or ECHA (website: www.echa.europa.eu) is the EU body that is responsible for REACH.The local Health Authorities also share responsibility in each Member State (Country) in the E.U.There can be enforcement action from any and all 28 countries in the E.U

What can happen if I don’t comply?

Penalties are multi-faceted.

1) Any products containing the chemical that is not registered will be immediately quarantined and cannot be shipped or sold until the authorities are satisfied that registration is complete, which can cause long-term supply chain interruption.

2) Each of the 28 Member States has the authority to demand a recall of those products, even if there is no immediate health threat to the consumer.

3) In addition, monetary penalties apply in virtually all cases.

Pre-registration is an easy way to avoid these catastrophic effects to a business.

Microbeads – will this ever end?

This may seem to be a strange question, but in light of all of the enforceable Microbeads regulations and budding legislation, it is strangely relevant.

Plastic microbeads: how this started

A little background: An article in the Los Angeles Times. publicized the questionable presence of microbeads, theoretically from cosmetics, found in the Great Lakes. It has not been determined precisely if they are indeed coming from Cosmetics/personal care products. However, cosmetics were easy to target as a source, since they are perceived to be frivolous products.

In an unlikely turn of events, Illinois was the first area to legislate the removal of microbeads in Cosmetics. Illinois, which borders the Great Lakes, passed legislation while working closely with the Industry through the Personal Care Products Council, negotiating a reasonable timeline for all concerned. The immediate problem of a short-term ban was abated, and a coherent, relevant definition of a microbead was created.

California

California also unsurprisingly presented legislation along the same lines as the Illinois bill, AB 888. Governor Brown signed the Bill into law in October 2015. It prohibits for “sale or offering for promotional purposes….

“a personal care product containing plastic microbeads that are used to exfoliate or cleanse in a rinse-off product”.

The U.S.

The Microbead-free Waters Act passed in December 2015, whose purpose is “to ban rinse-off cosmetics that contain intentionally-added plastic microbeads beginning on January 1, 2018, and to ban manufacturing of these cosmetics beginning on July 1, 2017.” If the microbeads are in a product that is categorized as an OTC Drug, there is an additional year to comply with the aforementioned deadlines.

Europe

The activity in the U.S. created interest in Europe, and as a pre-emptive measure, the EU cosmetics trade association, Cosmetics Europe, published recommendations to the industry for the phase-out of microbeads, by recommending “discontinue, in wash-off cosmetic products placed on the market as of 2020: The use of synthetic, solid plastic particles used for exfoliating and cleansing (i.e. microbeads) that are non-biodegradable in the marine environment.” Industry was committed to this responsible and reasonable guideline. Cosmetics Europe surveyed the industry in 2016, and found an 82% reduction in the number of products in Europe containing microbeads by the end of 2015. The European Commission is also currently developing proposals to ban them in cosmetics across the EU, following calls from a number of member states.

India

Other areas have heard of this activity and India, of all places, has requested a report on the use of microbeads, based on a petition from a lawyer from Delhi, requesting a ban on microbead-containing cosmetic products. At this time, there has been no proposed date for the ban.

Australia and New Zealand

New Zealand’s Ministry of the Environment has released a consultation document on a ban of microbeads on rinse-off products, which potentially would begin July 1, 2018.

The Australian government has a recommended ban of July 1, 2017. If significant amounts of product are still on the market at that time, the government will likely issue a mandatory ban for 2018.

And that’s not all, folks….

The consumer action group Greenpeace has also said that "Marine life doesn't distinguish between plastic from a face wash and plastic from a washing detergent, so the ban should be extended to microplastics in any product that could be flushed down the drain.”

The Environmental Working Group, a nonprofit who is no stranger to our industry, also stated: “Taking action on microbeads was an important first win. But it’s even more important to make sure we are really addressing environmental plastic pollution.” The net is beginning to widen for definitions of “marine waste”, or physical contaminants in waterways.

The BBC encourages consumers to look for specific ingredients on the label, since “microbeads” is not an INCI name. “Instead, look for the words polyethylene, polypropylene and polymethylmethacrylate - the chemical names for plastics. Nylon may also be listed as well as the abbreviations PET, PTFE and PMMA.”

This can serve to confuse the consumer, as they may misinterpret an ingredient name that contains “polyethylene” as part of its INCI designation, which would not fit the definition of a microbead. It would be categorized chemically as a polymer, and would not be what a consumer would consider to be “plastic”. However, under the loose descriptions being used by consumer groups, and in some of the draft legislation, we could be faced with some unintended consequences.

Action by Industry

Industry must be clear on the definition of microbeads and work with legislators, since some pending legislation now refers to microplastics, which may include materials which are simply chemically related, such as liquid polymers, and should not be considered as “marine waste”.

Even as companies are completing the required 2013 survey data, the new second phase 2014 surveys have been identified.

Data for 2014 product sales must be submitted beginning July 1, 2015. This is also the same day as the extended deadline for the small companies for 2013 data submissions.

Hurry -- these survey dates are close upon us.

International Cosmetics is creating e-Survey compliance for clients on a first-come first-served basis. Don't waste your summer vacation trying to do what an expert can accomplish for you!

According to CARB, ARB staff is gathering data about Consumer and Commercial products that were sold or supplied for use in California during calendar years 2013-2015.

For reporting calendar year 2014 and 2015 data, all sales information will need to be reported by product UPC. Updated ingredients information only will need to be provided for modified product formulas or new products.

Contact International Cosmetics today! Our CARB-reporting compliance staff is here to make it easy for you.

Attention Brand Owners! The deadline for filing information on your VOCs is almost here! This is a legal obligation and mandatory for any VOCs product sold in California, no matter where it is made (NY, Australia, Japan, Europe, China, etc.). It is your responsibility as a brand owner, no matter if you own the formula or not. CARB (California Air Resources Board) will make no excuses!

Written by Janet Winter Blaschke for Society of Cosmetic Chemists Newsletter - October 2014

Those of us who were around in the early 1990s remember the discourse (read: bloodshed) around the initial California Volatile Organic Compounds (VOC) Consumer Products regulations, primarily focused initially on Hairsprays. As everyone suspected, the new VOC regulations changed our hairspray formulas in the US forever. Hairsprays were calculated to contribute a significant amount to air pollution by use of traditional propellants and alcohol, which all fit the definition of a VOC. Other categories affected initially included Air Fresheners, Adhesives, Automotive Fluids, Bathroom cleaners, among others.

The next generation brought more regulations on Antiperspirants/Deodorants and Hair Styling products in our niche of the Consumer Products industry. Other industries were once again included.

California is now preparing to restrict VOCs in other product categories, and increase requirements on existing categories. The Air Resources Board has published its survey, and completing this survey is a legal obligation for companies selling products in California in any of the survey categories. The categories required by this new survey are:

1. Antiperspirants and deodorants: traditional products as well as foot deodorant, feminine Hygiene and “other” APs and deos;

….and not to worry, Automobile emissions are continually subject to new restrictions. They are handled outside of the Consumer Product category.

It is important to note that any company selling products in California in these categories will be required to complete the survey. Products manufactured outside of California are not exempt.

The last comprehensive survey such as this was done in 2003. This new survey is unique in several ways.

1. The information requirements are much more detailed, and in most cases require almost the entire formula to be divulged.

2. Companies must specifically note not just “fragrance” as an ingredient, but the fragrance supplier and the item number and fragrance name must be listed.

3. There is no minimum level of sales per product, so technically if only 5 bottles of product were sold, that is still reportable.

4. Every individual SKU must be submitted, including for example, sample sizes, gift with purchase items, and multiple sizes of the same formula.

5. Each product and each size registered must be identified by a number as shown as a UPC on the package. If the product does not have a UPC for some reason, other readily available identifying information must be used, per product, per size.

6. It is now clear that the brand owner is responsible for the survey for their products. The Contract Manufacturer or downstream distributor is not responsible for the filings. As a general rule, the name of the company on the product indicates the responsible party.

As we all know, some of what is now required is highly sensitive information. However, completing the survey is required by law for any/all of the above categories of products. It can be labeled as confidential business information (CBI) however the information that is required will have to be available within the supply chain (for instance, a contract manufacturer will have to make the formula available for submission).

If past history repeats itself, the California Air Resources Board (CARB) will be very diligent in their follow up with companies obligated to complete the survey. My advice follows.

1. If you receive notification of the survey, complete it as required. If you do not, CARB will continue to follow up with you, until the obligations are fulfilled.

2. If you know you have products in any of these categories and don’t receive notification of the survey from CARB, contact them. You are still under obligation to fulfill this responsibility, and fines can result from non-compliance.

3. If you do not have any products in these categories, you must be in another industry!

But don’t feel too badly- there are a number of other industries that have products on the draft Survey. A sampling:

Flying and Crawling bug insecticides

Caulking compounds

Disinfectants

Air Fresheners

All manner of cleaners

Dish Detergents

Spot removers

Aerosol cooking Sprays

CARB also performs random testing on products off the retail shelves, as some companies in our industry already know. Between the testing and results of the surveys, new VOC limits will be created for at least some of the categories listed above.

Janet Winter Blaschke is a well-known worldwide Regulatory expert. She is a Qualified Safety Assessor in the EU, with over 25 years’ experience in US and International markets, and a frequent speaker in the industry. She is the owner of ICRS, LLC (US) and ICCS (UK), which are full service regulatory consulting firms.